European Pharmacopoeia adopts new standards to promote the development of mRNA vaccines
The European Pharmacopoeia (EP) Commission announced the approval of three new general standards addressing the production and quality control of monovalent messenger ribonucleic acid (mRNA) vaccines and their components to promote their development in preventing infectious diseases.This action follows up on the EP announcement from April 2024, which sought public feedback on these standards. The EP stated last year that the field of mRNA vaccines has developed rapidly in recent years and continues to grow as an essential technology for against infectious diseases.
The decision was made during the 180th session of the commission meeting held in Strasbourg on 19 November.
The EP said that the development and approval of COVID-19 mRNA vaccines have provided significant momentum and are setting the stage for new vaccines that encode various specific antigens. This situation “highlights the necessity for unified quality standards for mRNA vaccines throughout Europe and beyond.”
The adoption of these texts will “support developers and manufacturers of these novel products, as well as the regulatory agencies and national control laboratories worldwide that regulate them, by providing a framework of requirements for the production and control of mRNA vaccines.”
The standards include 5.36, which covers mRNA vaccines for human use, including mRNA packaged in lipid nanoparticles such as mRNA-LNP products; standard 5.39, which covers mRNA substances used in the manufacturing of mRNA vaccines; and standard 5.40, which covers the DNA templates to use as starting material for preparing mRNA substances.
The European Parliament stated that this action results from collaborative efforts within the mRNAVAC Working Party, a diverse group of specialists from industry, academia, licensing authorities, and national control laboratories around the world.
The mRNAVAC Working Party was established after the EDQM Nanomedicines Symposium held in June 2022. Its purpose is to build on the ideas shared by stakeholders during the event and to integrate the experiences gained from mRNA vaccines both during and after the pandemic.
mRNA vaccines are currently being studied for various infectious diseases, as well as for their potential in treating heart disease and strokes.
The new texts will be published in the Ph. Eur. in July 2025.
EDQM announcement
